Z-2075-2021 Class II Terminated
FDA device recall Z-2075-2021 was initiated by C-RAD POSITIONING AB on August 6, 2020 and is designated Class II. Reason for recall: PC Application Software c4D not changing Site upon synchronization during the Setup workflow step The recall status is terminated (terminated April 15, 2022). Affected quantity: 7.
Recall Details
- Product Type
- Devices
- Report Date
- July 21, 2021
- Initiation Date
- August 6, 2020
- Termination Date
- April 15, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7
Product Description
PC Application Software c4D as part of the device Catalyst: SP-002 Software PA-003 version 6.1.1 and 6.1.0
Reason for Recall
PC Application Software c4D not changing Site upon synchronization during the Setup workflow step
Distribution Pattern
US Nationwide distribution in the states of IL, KY, MO and WA.
Code Information
Catalyst: SP-002, Software (part number): PA-003 version 6.1.1 and 6.1.0